Skip to main content
OpenTrials
Completed

NCT Number: NCT01191073

Manually Versus Digitally Fabricated Removable Partial Dentures

In the clinical trial, the Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) fabricated removable partial dentures (RPD's) are evaluated on casts and clinically compared with a traditional fabricated RPD for 50 consecutive patients.

During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, … of both groups of dentures.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

About this study

The classic removable partial denture (RPD) is a denture fabricated in CrCo using the "lost wax" technique. This hand-made way of working makes the final result vulnerable, not always predictable and not reproducible.

Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) techniques have been introduced in dentistry, particularly to fabricate crowns and bridges (fixed partial dentures). There is little research in the field of removable partial framework fabrication. This may be in part be attributed to the lack of suitable dedicated software.

In the technical part of the study, existing software and hardware is adjusted to maximize the automation in the application of computer-aided technologies to surveying of digital casts and pattern design and the subsequent production of sacrificial patterns using removable partial (RP) technologies.

In the clinical trial the CAD/CAM fabricated RPD's are evaluated on casts and clinically and compared with a traditional fabricated RPD for 50 consecutive patients. For every patient, two RPDs are made in the same material (CrCo).The clinical parameters (fit, stability, retention, support, friction) are double blind evaluated by two dentists. At the end of the treatment, the patient can choose one of them.

Both RPDs are fabricated in the same time frame for the fabrication of the "classic" RPD. There are for the patient no extra sessions scheduled.

During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, … of both groups of dentures.

Hypothesis1: CAD/CAM fabricated RPD's can meet the clinical standards for RPD's.

Hypothesis 2: Dentists do not observe a difference between the classic and CAD/CAM fabricated RPD.

Hypothesis 3: Patients do not see/feel any difference between the classic and CAD/CAM fabricated RPD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients in need of a classic removable partial denture (RPD)

Treatment and study plan

CAD/CAM fabricated RPD's

Device

group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)

traditional fabricated RPD's

Device

group receiving traditional fabricated dentures (double blind)

Primary outcomes

  1. fit of framework

    Time frame: 9 months

    After casting "fit of the framework" between two identical reomvable partial dentures (same design, looks, material...) fabricated in a different way.

Secondary outcomes

  1. placement of RPD + control of placement

    Time frame: 3 to 5 days

    There will be a placement of a removable partial denture, and after 3 to 5 days, this placement will be re-checked as a follow up.

  2. re-evaluation of the RPD placement

    Time frame: every 6 months, for 5 years

    Every 6 months, for 5 years, the RPD placement will be followed up.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

A Study on the Fit and Behaviour of Computer-aided Design and Rapid Prototyping Fabrication of Removable Partial Dentures

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 30, 2010
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.